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CTRI Number  CTRI/2019/07/020274 [Registered on: 19/07/2019] Trial Registered Prospectively
Last Modified On: 18/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the effect of three drugs- methotrexate, apremilast and their combination in patients suffering from psoriasis vulgaris. 
Scientific Title of Study   Comparative efficacy of methotrexate, apremilast and their combination in psoriasis vulgaris. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nainika Goel 
Designation  PG-JR 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of dermatology, D block, 5th floor, GMCH, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  09711249607  
Fax    
Email  dr.nainika1311@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr GP Thami 
Designation  Professor and Head of Department 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of dermatology, D block, 5th floor, GMCH, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  8847362431  
Fax    
Email  thamigp@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Nainika Goel 
Designation  PG-JR 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of dermatology, D block, 5th floor, GMCH, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  09711249607  
Fax    
Email  dr.nainika1311@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Chandigarh 
 
Primary Sponsor  
Name  Department of Dermatology 
Address  D- block, 5th floor, GMCH, Sector 32, Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nainika Goel  Government medical college and hospital, Sector 32  Room number 4311, Dermatology OPD, B block, 4th floor.
Chandigarh
CHANDIGARH 		 09711249607

dr.nainika1311@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Apremilast  Oral apremilast 30 mg BD, starting at 10 mg/day with an increment of 10 mg/day over 5 days, for 8 weeks. 
Comparator Agent  Methotrexate  Oral methotrexate 0.2 mg/kg/week, maximum 25 mg/week for 8 weeks. 
Intervention  Methotrexate plus apremilast  Oral methotrexate 0.2 mg/kg/week, maximum 25 mg/week along with oral apremilast 30 mg BD, starting at 10 mg/day with an increment of 10 mg/day over 5 days, for 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of psoriasis vulgaris requiring systemic therapy. (Body surface area > 10% or
PASI score > 10 or non-responsive to topical therapy)
2. Patients above the age of 18 years.
3. Patients consenting for contraception required for methotrexate therapy. 
 
ExclusionCriteria 
Details  1. Patients suffering from any other significant systemic illness.
2. History of anti-psoriatic treatment in the last 2 months.
3. Pregnant or lactating women. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of apremilast and methotrexate and their combination in patients of psoriasis vulgaris by comparing the PASI score before and after commencement of the therapy.
 		 0,2,4,6,8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety of all the three treatment modalities by assessing the side effects.  0,2,4,6,8 weeks. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/07/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N.A. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Psoriasis is a common, chronic, non-contagious inflammatory skin disorder characterized by sharply demarcated, red plaques with silvery white scaling, which may occur on any part of the body but preferentially over extensor areas and scalp. While methotrexate is highly efficacious, the wide array of side effects restrict its use in the long term and mandate the need for strict periodical monitoring and a limited total cumulative dose. On the other hand, apremilast is a relatively safer drug but its efficacy in Indian population is not yet established. The present study aims to assess its efficacy and compare it with the gold standard, methotrexate. Since no single drug is completely effective in the treatment and maintenance of this chronic disease, the present study also aims to assess the efficacy of the combination of two drugs to ascertain if apremilast could enhance the efficacy of methotrexate, leading to less adverse effects, reduced dosage and duration of therapy of methotrexate. 
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